Impact of nefazodone on sleep architecture in insomnia

ISRCTN	ISRCTN84604889
DOI	https://doi.org/10.1186/ISRCTN84604889
Secondary identifying numbers	N0038104044

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Jane Hicks
Scientific

Cottham House
Cottham Hill
Bristol
BS16 1JB
United Kingdom

Phone	+44 (0)117 9 427 373
Email	abc@123.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Impact of nefazodone on sleep architecture in insomnia
Study objectives	Does nefazodone improve sleep in insomnia?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Insomnia
Intervention	1. Nefazodone 2. Placebo This is a double blind placebo-controlled crossover study to look at the effects of nefazodone on sleep in insomnia. Patients will be given a two week washout from any psychotropic medication and then randomised to take either 100 mg of nefazodone or placebo for 2 weeks with a 2 week washout, then cross over to the treatment. At the end of the each 2 weeks their overnight sleep will be measured at home by polysomnography and they will be asked to fill in questionnaires about their sleep. Objective and subjective sleep measures will be compared in subject between the two treatment periods.
Intervention type	Other
Primary outcome measure	1. Objective Total Sleep Time 2. Subjective Sleep Quality
Secondary outcome measures	All other measures of objective and subjective sleep
Overall study start date	01/10/2001
Completion date	30/09/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients aged 18 to 65 meeting criteria for insomnia (International Classification of Sleep Disorders) and without: use of other psychotropic drugs, allergy to nefazodone, current or past severe mental illness or substance abuse, current depressive illness.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2001
Date of final enrolment	30/09/2003

Cottham House

Bristol
BS16 1JB
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

Avon and Wiltshire Mental Health Partnership NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

28/09/2018: No publications found, all search options exhausted, study status unverified.